510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K911587Substantially Equivalent

K-Sol(tm)

Alcon Laboratories, Fort Worth TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K911587 is the FDA 510(k) clearance record for K-SOL(TM), a class II device, cleared for Alcon Laboratories on under FDA product code KDN (System, Perfusion, Kidney). FDA records list 152 510(k) clearances for Alcon Laboratories, from to . As of , FDA records show no recalls naming K911587.

Clearance record

Decision date
Received
(206 days to decision)
Product code
KDN System, Perfusion, Kidney
Regulation
21 CFR 876.5880
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Alcon Laboratories 6201 S. Fwy. R7-14, Fort Worth TX
Third party review
No

Clearances, product code KDN

Trailing 12 months
3 clearances under product code KDN in the twelve months to November 2026, January 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code KDN, trailing twelve months
MonthClearances
December 20250
January 20261
February 20260
March 20260
April 20260
May 20260
June 20261
July 20261
August 20260
September 20260
October 20260
November 20260